临床试验/NCT01941394

NCT01941394Unknown2 期

Pilot Study for Safety and Effectiveness Assessment of Bone Marrow Mesenchymal Stem Cell Infusion for Acute Graft-versus-host Disease Prophylaxis and Treatment After Allogenic Bone Marrow Transplantation

National Research Center for Hematology, Russia1 个研究点分布在 1 个国家目标入组 70 人开始时间: 2007年10月最近更新: 2013年9月13日

适应症

干预措施

试验速览

阶段: 2 期
发起方: National Research Center for Hematology, Russia
入组人数: 70
试验地点: 1
主要终点: GVHD

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Infusion of Mesenchymal Stem Cell (MSC) at day of recovery after bone marrow transplant (BMT) for patients with AL, AA and MM for acute Graft-versus-host Disease (GVHD) prophylaxis and treatment.

详细描述

Infusion of mesenchymal stem cells at day of recovery after BMT for patients with AL, AA and MM for acute GVHD prophylaxis and treatment. Infusion at dose 1 cells mln/kg at day of white blood cells recovery.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: None

入排标准

年龄范围: 18 Years 至 60 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•allogenic BMT from related or unrelated donor

排除标准

•Severe infection
•admission to ICU
•refusal of research
•patients with graft failure

研究组 & 干预措施

With MSC

Experimental

infusion of Mesenchymal stem cells at dose 1 mln cells per kg

干预措施: Mesenchymal stem cells (Biological)

结局指标

主要结局

GVHD

时间窗: Every 30 day for 1 year after BMT

次要结局

Overall survival(Every 30 day for 1 year after BMT)
Relapse-free survival(Every 30 day for 1 year after BMT)
Infection rate(Every 30 day for 1 year after BMT)

研究者

发起方

National Research Center for Hematology, Russia

申办方类型

Network

责任方

Principal Investigator

主要研究者

Elena N.Parovichnikova

Head of BMT department

National Research Center for Hematology, Russia

研究点 (1)

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